Clinical trials: Bone Conduction Deafness
Conductive Hearing Loss, Unilateral Partial Deafness
Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.
- Conditions
- Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Conductive-sensorineural Hearing Loss
- Trial name
- C50 (NCT02438618)
- Testing
- Surgery for Ponto bone anchored hearing aids
- Where
- Netherlands
- Volunteers
- 64 people
- Sponsor
- Oticon Medical
Deafness, Hearing Loss
Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery.
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Disorders
- Trial name
- NCT01738490
- Testing
- Bone anchored hearing implant
- Where
- Netherlands
- Volunteers
- 59 people
- Sponsor
- Oticon Medical
Hearing Loss, Conductive, Hearing Loss Mixed
Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is…
- Conditions
- Hearing Loss, Conductive, Hearing Loss Mixed, Hearing Disability, Conductive Hearing Loss
- Trial name
- NCT04803279
- Testing
- Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower, Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower, Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower
- Where
- United Kingdom
- Volunteers
- 57 people
- Sponsor
- Oticon Medical
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Hearing Loss, Conductive, Bone Conduction Deafness
A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to randomize patients to receive either the Bonebridge or a conventional bone conducting hearing device.
- Trial name
- NCT01858246
- Testing
- Bonebridge, Bone Anchored Hearing Aid
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Ninewells Hospital
Deafness, Hearing Loss
Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery: To describe the expected…
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive
- Trial name
- NCT01822119
- Testing
- Baha Attract System
- Where
- 4 sites in Australia, Chile and 2 more
- Volunteers
- 27 people
- Sponsor
- Cochlear Bone Anchored Solutions
Hearing Loss, Mixed, Hearing Loss, Conductive
Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients
The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to demonstrate its superiority compared with the Osia 2 Sound Processor in adults with mixed…
- Conditions
- Hearing Loss, Mixed, Hearing Loss, Conductive, Single-Sided Deafness, Bone Conduction
- Trial name
- SONUS (NCT07156461)
- Testing
- Cochlear™ Osia® System (Osia® 2), Cochlear™ Osia® System (Osia® 3)
- Where
- 3 sites in United States, Australia
- Volunteers
- 29 people
- Sponsor
- Cochlear
Hearing Loss, Conductive
Remote Microphone (RM) - A Comparative Study
The purpose of this investigation is to evaluate objective outcomes in pediatric bone conduction hearing device (often termed "BAHA") users with and without remote microphone (RM) technology.
- Trial name
- NCT04147611
- Testing
- BAHA, Wireless Audio Streaming Accessory, Digital Adaptive RM System
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Miami
Unilateral Hearing Loss
Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
The purpose of this study is to determine the safety and efficacy of using bone conduction via the teeth to treat Single-Sided Deafness (SSD).
- Trial name
- NCT00977314
- Testing
- The Sonitus Bone Conduction Hearing System, SoundBite, SoundBite Hearing System
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Sonitus Medical Inc
Deafness, Hearing Loss
Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for…
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive
- Trial name
- NCT02022085
- Testing
- Baha Attract System
- Where
- 6 sites in United States, Netherlands and 2 more
- Volunteers
- 54 people
- Sponsor
- Cochlear Bone Anchored Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)
A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and a sound processor connected with the implant.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Deafness
- Trial name
- Baha (NCT01264510)
- Testing
- audiological test battery
- Where
- Belgium
- Sponsor
- University Hospital, Ghent
Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive
Sentio Systematic Evaluation
The study is designed as an international, multi-center, single-armed, non-interventional/observational study including subjects who has received or are planned to receive the Sentio system as part of normal clinical practice.
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Single Sided Deafness
- Trial name
- SENSE (NCT07161154)
- Testing
- Transcutaneous bone conduction hearing system
- Volunteers
- 100 people
- Sponsor
- Oticon Medical
Hearing Impaired Children, Hearing Impairment, Conductive
Single-stage Surgery Using the BI300 Implant
Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure.
- Trial name
- NCT04038216
- Testing
- Single-stage surgery, Two-stage surgery
- Where
- Netherlands
- Volunteers
- 70 people
- Sponsor
- Radboud University Medical Center
Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis), Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side
Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population
To study the initial experience with implanting and fitting a new Bone Conduction system in pediatric patient population with conductive, mixed or single-sided deafness.
- Trial name
- OSIA Pediatric (NCT03509974)
- Testing
- Osseointegrated Steady State Implant
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Cochlear
Hearing Impairment, Conductive, Hearing Impaired Children
Single-stage Surgery Using the BHX Implant
Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure.
- Trial name
- NCT04039802
- Testing
- Single-stage surgery, Two-stage surgery
- Where
- Netherlands
- Volunteers
- 70 people
- Sponsor
- Radboud University Medical Center
Retrocochlear Pathology, Auditory Processing Disorder, Central
Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.
The investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be…
- Conditions
- Retrocochlear Pathology, Auditory Processing Disorder, Central, Major Cochlear Ossification or Malformation
- Trial name
- CISSD (NCT02204618)
- Testing
- cochlear implantation, 6 months initial abstention
- Where
- France
- Volunteers
- 160 people
- Sponsor
- University Hospital, Toulouse
Chronic Otitis Media, Tympanic Membrane Perforation
Comparison of Postoperative Outcomes of Interlay vs Underlay Graft in Tympanoplasty
Chronic otitis media is a long-term ear infection that may cause a hole in the eardrum, leading to repeated ear discharge and hearing loss.
- Conditions
- Chronic Otitis Media, Tympanic Membrane Perforation, Conductive Hearing Loss
- Trial name
- NCT07149480
- Testing
- Underlay Tympanoplasty, Interlay Tympanoplasty
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Shaikh Zayed Hospital, Lahore
Conductive Hearing Loss, Unilateral Partial Deafness
Clinical Survey of Different Abutment Topologies
This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.
- Conditions
- Conductive Hearing Loss, Unilateral Partial Deafness, Mixed Hearing Loss
- Trial name
- NCT02304692
- Testing
- Bone anchored hearing aid
- Where
- Sweden
- Volunteers
- 14 people
- Sponsor
- Oticon Medical
Hearing Loss, Conductive, Hearing Loss, Mixed
Pediatric Expansion Study of the Sentio System
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
- Trial name
- BC119 (NCT06976086)
- Testing
- Active transcutaneous bone conduction system
- Where
- 8 sites in Netherlands, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Bone Conduction Deafness, Unilateral Deafness
Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and…
- Conditions
- Bone Conduction Deafness, Unilateral Deafness, Middle Ear Deafness, Mixed Hearing Loss
- Trial name
- NCT03281967
- Testing
- Minimally Invasive Ponto Surgery
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Oticon Medical